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Trial record 69 of 419 for:    TRANEXAMIC ACID

Study of the Effect of Tranexamic Acid Administered to Patients With Hip Fractures. Can Blood Loss be Reduced?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01535781
Recruitment Status : Terminated (Recruiting slower than expected.)
First Posted : February 20, 2012
Last Update Posted : February 5, 2015
Information provided by (Responsible Party):
Peter Toft Tengberg, Hvidovre University Hospital

Brief Summary:

The effect of Tranexamic acid on blood loss, hemoglobin and transfusions in patients with pertrochanteric hip fractures.

Tranexamic acid is a well known drug used in many types of surgery. The investigators wish to investigate if the use of tranexamic acid can reduce the peri- and post-operative blood loss in patients who undergo surgery with a short intramedullary nail, for a pertrochanteric hip fracture.

An interim analysis was planned when reaching 60 inclusions. The interim analysis was conducted only on the primary outcome (TBL). A difference in TBL of no less than 500 ml was considered a reason to halt the study. The 0.001 level was chosen as a simple approach to this interim analysis from the Haybittle-Peto boundary

Condition or disease Intervention/treatment Phase
Hip Fracture Anemia Drug: Tranexamic Acid Drug: Placebo Not Applicable

Detailed Description:

Studies have shown that hip fractures have a hidden blood loss besides the recorded perioperative blood loss. Patients who are osteosynthesised with an intramedullary nail have been shown to have the largest hidden blood loss.

Postoperative anaemia is associated with a higher morbidity and mortality. We wish to investigate the possibility of reducing this hidden blood loss, with the use of a well known drug (tranexamic acid) that is widely used to reduce blood loss in other forms of surgery and in multitraumatized patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Tranexamic Acid on Blood Loss and Transfusion Need in Patients Operated With a Short Intramedullary Nail, for Pertrochanteric Fractures .
Study Start Date : September 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo
Patients are given saline instead of tranexamic acid in the placebo group
Drug: Placebo
Identical syringe and drip used as in the intervention, to ensure blinding.
Other Name: Saline

Active Comparator: Tranexamic Acid
Tranexamic acid; 1 gram as a bolus prior to surgery. 3 grams of Tranexamic acid in 1 liter of saline as a 24 hour infusion.
Drug: Tranexamic Acid
1 g of tranexamic acid as a bolus immediately before surgery 3 g of tranexamic acid in 24hours postop.
Other Name: Cyklokapron (tranexamic acid)

Primary Outcome Measures :
  1. Total Blood Loss [ Time Frame: time in hospital (approximately 10 days) ]
    Calculated as described by Foss et al in their study of 2006. "Hidden Blood Loss After Surgery for Hip Fracture" JBJS br. 2006.

Secondary Outcome Measures :
  1. Transfusions [ Time Frame: From admission to third day after surgery. ]
    Information from local blood bank

  2. Mortality [ Time Frame: 30 days and 90 days follow up ]
    Mortality is obtained via central personal registration system (Danish CPR system)

  3. Thromboembolic Event (clinical, NOT by routine ultrasound measurement) [ Time Frame: 90 days follow up ]
    Obtained in-hospital, through routine check ups daily. After discharge; obtained from patient records.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients planned to undergo osteosynthesis with short intramedullary nail for a pertrochanteric hip fracture.
  • ASA score 3, 2 or 1

Exclusion Criteria:

  • Allergy for tranexamic acid
  • Clinical signs of acute thromboembolic event
  • Renal function impairment (S-creatinin>120micromol/l)
  • Active thrombotic disease or DIC
  • K-vitamin antagonist treatment
  • Malignancy
  • Pathological fracture
  • Previously operated in same hip
  • BW > 100kg

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01535781

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Hvidovre Hospital
Hvidovre, Copenhagen, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
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Principal Investigator: Peter T Tengberg, MD Hvidovre University Hospital
Study Chair: Henrik Palm, MD Hvidovre University Hospital
Study Director: Anders Troelsen, PhD Hvidovre University Hospital
Study Chair: Michael Krasheninnikoff, MD Hvidovre University Hospital
Study Chair: Nicolai B Foss, PhD, Dr.Med Hvidovre University Hospital

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Responsible Party: Peter Toft Tengberg, MD, Hvidovre University Hospital Identifier: NCT01535781     History of Changes
Other Study ID Numbers: TA0001
First Posted: February 20, 2012    Key Record Dates
Last Update Posted: February 5, 2015
Last Verified: February 2015
Keywords provided by Peter Toft Tengberg, Hvidovre University Hospital:
pertrochanteric fracture
tranexamic acid
postoperative blood loss
blood loss
hidden blood loss
blood transfusions
Additional relevant MeSH terms:
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Tranexamic Acid
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Pathologic Processes
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action